Adverse Event
Conditions
Keywords
Norepinephrine, Hydroxyethyl starch, Postspinal anesthesia hypotension, Coload, Cesarean section
Brief summary
The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
Detailed description
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
Interventions
DRUGNormal saline
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
DRUGNorepinephrine (0.025 μg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
DRUGNorepinephrine (0.075 μg/kg/min)
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Criteria: Inclusion Criteria: * 18-40 years * Primipara or multipara * Singleton pregnancy ≥ 37 weeks * American Society of Anesthesiologists physical status classification I to II * Scheduled for elective cesarean section under spinal anesthesia
Exclusion criteria
* Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg * Hemoglobin \< 7g/dl * Coagulation or renal function disorders * Known allergy to hydroxyethyl starch * Fetal distress, or known fetal developmental anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-spinal anesthesia hypotension | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 80% of the baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of severe post-spinal anesthesia hypotension. | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \< 60% of the baseline. |
| The incidence of nausea and vomiting. | 1-15 minutes after spinal anesthesia | Presence of nausea and vomiting in patients after spinal anesthesia |
| The incidence of bradycardia. | 1-15 minutes after spinal anesthesia | Heart rate \< 55 beats/min. |
| The incidence of hypertension. | 1-15 minutes after spinal anesthesia | Systolic blood pressure (SBP) \>120% of the baseline. |
| Overall stability of systolic blood pressure control versus baseline | 1-15 minutes after spinal anesthesia | Evaluated by performance error (PE). |
| Partial pressure of oxygen | Immediately after fetal delivery | Analyse from umbilical arterial blood gases. |
| Concentration of base excess | Immediately after fetal delivery | Analyse from umbilical arterial blood gases. |
| Apgar score (0-10; a higher score means a better outcome) | 5 min after fetal delivery | A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2) |
| Apgar score (0-10;a higher score means a better outcome) | 5 min after fetal delivery | A= Appearance (0-2); P=Pulse (0-2); G=Grimace (0-2); A=Attitude (0-2); R=Respiration (0-2) |
| pH value | Immediately after fetal delivery | Analyse from umbilical arterial blood gases. |
Countries
China
Outcome results
None listed